No of openings: 1

Experience : 3 to 5 yrs experience in Clinical Operations.

Job Description :

• Training the teams and new employees regularly and periodically.
• Negotiating the study budgets with the Principal Investigator and executing the Clinical Trial Agreement.
• Assigning and Managing the project team as per the study requirement.
• Development and Revision of departmental SOPs.
• Reviews CRA Site Visit documents (follow up letters and reports).
• Reviews and Approves the travelling plan and budgets of the monitors.
• Updating the sponsor about the progress of the study as agreed in the contract.
• Participating in telecoms with the clients and kick of meetings.
• Hosting the external audits.
• Preparing Monitoring plan for the CRA as per the study specifications and protocol and training the CRA on the same.
• Training the team on study related documents.
• Managing and coordinating all regional CRA activities.
• To perform co-monitoring visits to ensure quality of data generated
• If required accompanying the CRA’s in Qualification visit, Site Initiation Visit and Monitoring visits.
• Organize and present at Investigator Meetings/ Internal meetings.
• Development of project management plan, risk management plans.
• Review the Ethics Committee dossiers as required.
• Review of power point presentations prepared by CRA for investigator meetings, Site Initiation visits.

No of openings : 05

Job Code: CRAOO1A

Experience: 1 to 4 yrs in Clinical Research Associative.

Job Description :

• Responsible for conduct of Qualification visit, Site Initiation Visit, Monitoring Visit and Closeouts visit.
• Would be the first point of contact for Communication with the Investigators and site personnel’s for the study assigned.
• Coordinate the movement of Laboratory samples if applicable.
• Ensuring the data entry/CRF filling, following-up visits of subjects as per the protocol.
• Prepares follow up letters and reports for the respective visits as per the SOPs and share with the site and Sponsor as required.
• Follow-up with the coordinator for the query resolution.
• To collect the collated Ethics Committee documents from CTA for EC submission as defined in site SOPs.
• To ensure that the interim safety reports, interim study reports are provided to EC as per the governed regulatory body.
• Preparation of power point presentations for investigator meetings and Site Initiation visits.
• Managing the CRC activities, and training them periodically.